Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 97

Safety reporting by consumers and the healthcare community is purely voluntary, but strongly encouraged. (Exception: The US National Childhood Vaccine Injury Act (NCVIA) requires healthcare providers to report: (a) Any event listed by the vaccine manufacturer as a contraindication to subsequent doses of the vaccine; and (b) Any event listed in FDA’s Reportable Events Table that occurs within the specified time period after vaccination (see www.fda.gov for the latest Reportable Events Table).) Reports may be made to the FDA directly via MedWatch (mail, online, fax, etc.) or to the pharmaceutical company that manufactures, sells, or packages the product. Once a manufacturer (NDA holder or “Applicant”) or distributor, etc., learns of an adverse event for one of its products, reporting to FDA is mandatory.